Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC. (REICRAE)

February 2, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

Real-world Experience of Immunotherapy Plus Chemotherapy as First-line Treatment With or Without Radiotherapy for Patients With Advanced Oesophageal Squamous Cell Carcinoma in China

This study is a multi-center, non-interventional study. Clinicopathologic, treatment , outcome and efficacy data will be collected from medical records in metastatic esophageal squamous cell carcinoma (ESCC) patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell carcinoma (ESCC) patients who were treated with chemotherapy combined with immunotherapy as 1st line treatment at approximately 5 institutions. The patients should have received at least 1 cycle of immunotherapy and chemotherapy with or without radiotherapy. Based on these data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment and the role and efficacy of radiotherapy for these patients will be assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
728

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Cancer Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma.
  2. Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy;
  3. Pathologically diagnosed as esophageal squamous cell carcinoma;

Description

Inclusion Criteria:

  1. Pathologically diagnosed as esophageal squamous cell carcinoma;
  2. The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma.
  3. Patients had received no previous systemic therapy
  4. Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy;
  5. Complete medical records;
  6. ECOG0-2;

Exclusion Criteria:

  1. Surgery for esophageal cancer;
  2. Esophageal fistulae due to infiltration of the primary tumour.
  3. Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
  4. Those who have a history of autoimmune disease or have been treated with immunosuppressants within the last 3 months.
  5. Those who have received organ transplant surgery.

  6. Patients with a previous history of malignant tumor (skin basal cell carcinoma and cervical carcinoma in situ) survived tumor-free for 3 years after treatment.

    Except for the above).

  7. There are other serious diseases, such as myocardial infarction, cerebral infarction or severe cardiopulmonary insufficiency within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Arm A
Chemotherapy combined with immunotherapy group
Drug: Chemotherapy combined with immunotherapy
chemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors
Arm B
Chemotherapy combined with immunotherapy + radiotherapy group
Drug: Chemotherapy combined with immunotherapy
chemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors
Radiation: radiotherapy
Intensity-modulated radiation therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: up to 2 years
progression-free survival
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 2 years
Objective Response Rate
up to 2 years
DoR
Time Frame: up to 2 years
Duration of ResponseR
up to 2 years
RP
Time Frame: up to 2 years
recurrence recurrence pattern
up to 2 years
OS
Time Frame: up to 2 years
overall Survival
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
Shanxi Province Cancer Hospital
Henan Cancer Hospital
Hunan Cancer Hospital
The Fourth Hospital of Hebei Medical University
Sichuan Cancer Hospital and Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wencheng Zhang, M.D., Tianjin Medical University Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • bc2023043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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